Kornimate/medical-research-clean huggingface dataset:
dexamethasone infusion to the adventitia to enhance clinical efficacy after femoropopliteal revascularization

Conditions: Peripheral Arterial Disease

Summary: the purpose of this study is to test if dexamethasone, an anti-inflammatory medication approved by the us food and drug administration (fda), can be injected safely into the tissue around the blood vessel wall at the time of an angioplasty or atherectomy.

this is an investigator-initiated, single-arm, external pilot study to assess the safety and feasibility of perivascular administration of dexamethasone following endovascular superficial femoral and popliteal artery angioplasty or atherectomy. although dexamethasone is approved by the fda for injection into blood, skin or joints, it has not been approved by the fda for injection around blood vessels. the investigators want to find out if this procedure helps prevent re-narrowing of the blood vessel after angioplasty or atherectomy. the dexamethasone will be injected with a bullfrog® micro-infusion catheter, which is an fda-approved device for injecting medications into tissues around the blood vessel wall. the bullfrog® micro-infusion catheter is similar to other balloon tipped catheters except that it contains a microneedle covered by a fold of semi-rigid balloon. once the balloon is inflated, the microneedle is uncovered and a medication can be injected into the tissue around the blood vessel.

Eligibility criteria:
inclusion criteria: * patient is \> 40 years and \< 80 years of age * patient has severe, lifestyle-limiting claudication or critical limb ischemia (rutherford classification 3-6) * patient has tasc ii a, b or c disease, sfa revascularization is preferred over medical management, and endovascular approach is preferred revascularization strategy * patient has a resting abi of \<0.9 or an abnormal treadmill abi. patients with incompressible arteries must have a tbi \<0.8 * patient has at least 1 infra-popliteal run-off vessel with patency to the ankle without a \>50% stenosis * successful crossing of the lesion with guidewire and successful atherectomy or angioplasty with residual stenosis \<30% as compared to the reference vessels * atherectomy procedure does not result in embolization, arteriovenous fistula or perforation * patient agrees to return for a clinical assessment duplex ultrasound at 1, 3, 6, 9, 12 and 24 months (routine clinical care) exclusion criteria: * patient is simultaneously participating in another investigational drug or device study * patient is pregnant or breast-feeding * patient has cancer, autoimmune disease, bone marrow or organ transplant, or other concurrent medical illness requiring immunosuppressive therapy * patient has end-stage renal disease and chronic kidney disease (egfr\<30) * patient has an active infection * patient has a known hypersensitivity or contraindication to heparin, contrast agents, excipients of dexamethasone sodium phosphate injection, usp, dexamethasone, or other glucocorticoids * patient has a life expectancy of less than one year

Keywords: peripheral arterial disease femoral popliteal lesions
study using high-dose single fraction image-guided radiotherapy for metastatic lesions to soft tissue masses, lymph node, or bone

Conditions: Metastatic Disease

Summary: the purpose of this research study is to find out what ig-imrt radiation dose works best for treatment of disease in bone or soft tissues. this protocol will study what dose level may work most effectively. the first part of study will treat 10 patients with 22 gray. gray (gy) is the unit that is used to describe the dose of radiation that is being given to a person with cancer. after we confirm that 22 gy is a safe and sufficient amount of radiation, we will then treat another group of patients with 24 gy and so on until we reach 28 gy. each dose level starting with 24 gy will enroll at least 20 patients per treatment site (bone, bowel and/or spine). patients will be enrolled in each treatment category until 20 patients in each strata reach an evaluable time point of 3 months post-rt. when we understand what dose works best and has the least amount of bad effects, the study will then look to see how well the patients do after the radiation therapy. this study is trying to see how your doctor can best treat the cancer that has spread to the other parts of your body.


Eligibility criteria:
inclusion criteria: * biopsy-proven cancer verified at mskcc * imaging evidence of lymph node metastases, bone metastases or soft tissue disease * age \> or = to 18 years * kps \> or = to 80 * epidural disease is acceptable as long as the dose to the spinal cord ≤ 14 gy * able to tolerate immobilization cradle positioning exclusion criteria: * target lesion not visible on conventional ct scan * unable to be administered intravenous ct contrast safely * prior radiation to the planned target region. a second metastatic lesion would not be eligible if the area received or will receive any dose (5% or greater isodose line)from a prior or planned single fraction treatment * patients receiving concurrent chemotherapy (within 1 week of rt) * normal tissue directly overlying target precluding ability to limit the bowel, bladder, rectum or other tissue to 15-16 gy dose constraints * weight-bearing bones with significant cortical destruction from tumor. in these cases, patients will be referred for orthopedic consultation for rod stabilization procedures. * subjects with more than 4 metastases to bone * any metastatic lesion larger than 8 cm in its greatest diameter

Keywords: high does single fraction igrt bone lymph nodes soft tissue
efficacy of treatment for gestational diabetes diagnosed by the iadpsg criteria.

Conditions: Gestational Diabetes

Summary: there is a lack of international uniformity in the approach to the screening and diagnosis of gestational diabetes mellitus (gdm). the new diagnostic criteria by the international association of diabetes and pregnancy study groups (iadpsg) based on data from the study of hyperglycemia and adverse pregnancy outcomes (hapo) have created controversy because of the lack of clinical evidence of treatment benefit for mild gdm and the treatment effects on perinatal outcomes. the purpose of the present study is to know the efficacy of treatment to reduce adverse pregnancy outcomes in mexican women diagnosed with gdm by iadpsg criteria.

currently no evidence from randomized clinical trials on the efficacy of treatment of gestational diabetes mellitus (gdm), diagnosed by a single altered value during a 75g oral glucose tolerance test (75g ogtt), proposed by the international association of diabetes and pregnancy study groups (iadpsg) to reduce adverse perinatal outcomes (apo). in our institution gdm diagnosis is established with two or more altered values during 75g ogtt, women with one altered value during ogtt are not considered gdm and therefore those women do not receive specific treatment for gdm. we conduct an open randomized clinical trial, two groups, group 1 (women with treatment for gdm) and group 2 (women with routine care). the diagnosis of gdm will be perform with a single altered value during 75g ogtt: fasting ≥ 92mg / dl, 1-hour ≥ 180 mg / dl and 2-hours ≥ 153 mg / dl. treatment consist of medical nutritional therapy (mnt), which includes restricted diet 45% carbohydrate, exercise and self-monitoring of glucose, if not reach therapeutic goals metformin and / or insulin will be added.

Eligibility criteria:
inclusion criteria: * singleton pregnancy between 18-30 week´s gestation * 75-g oral glucose-tolerance test at 20-30 week´s gestation with only one altered value between: fasting 92-99 mg/dl 1. hour 180-211 mg/dl 2. hour 153-177 mg/dl exclusion criteria: * pregestational diabetes (first diagnosed in pregnancy) defined by altered values during 75-g oral glucose-tolerance test above: fasting \>126 mg/dl 2 hour \>200 mg/dl -two or more altered values during oral glucose tolerance test above: fasting 92 mg/dl 1. hour 180 mg/dl 2. hour 153 mg/dl * multiple pregnancy * active chronic systemic disease as hyperthyroidism, hearth, hepatic or renal disease, immunological disease as lupus and chronic hypertension
anxiety and depression disorder in patient treated with rtpa for mangment of acute ischemic stroke

Conditions: Acute Stroke; Anxiety Disorders; Depression

Summary: in fact theworld health organization estimates that 2-3% in general populations of countries across the world tend to be affected by severe mental disorders (1) thrombolytic therapy seems to be of great importance in achieving better quality of life in ischemic stroke patients who respond to this therapy(rtpa).

there is a substantial body of evidenc suggesting a strong relation between neurotrophic factors and depression and anxiety pathogenesis (2,8) brain-derived neurotrophic factor (bdnf), a member of the neurotrophic family known to regulate neuronal plasticity and survival , may play an important role in the pathophysiology of depression and anxiety (3,9). different studies indicated patients who were exposed to traumatic events have anxiety comorbidity and lower levels of serum bdnf compared to those without a history of traumatic events (4) . bdnf has an antidepressant and anxiolytic effect which suggest that bdnf is implicated in the regulation of anxiety-related behaviors. which leads to a valine-to-methionine change in the probdnf protein, was associated with lower activity-dependent secretion of bdnf (5)and has been implicated with increased susceptibility to neuropsychiatric disorders including depression, anxiety-related dysfunction, and bipolar disorder , all these studies suggest that bdnf is likely to be an important etiological factor in memory, depression and anxiety disorders (6,10). bdnf arises from a precursor, probdnf, which is cleaved to produce the mature protein through the tissue plasminogen activator (tpa) pathway, and represents one mechanism that can regulate the action of bdnfarises from a precursor, probdnf, which is cleaved to produce the mature protein through the tissue plasminogen activator (tpa) pathway, and represents one mechanism that can regulate the action of bdnf (7). the purpose of this study is to examine the quality of life after stroke of patients treated with thrombolysis .

Eligibility criteria:
inclusion criteria: 1. age more than 40. 2. none of the pt had history of other psychiatric illness. 3. male and female. exclusion criteria: * 1-smoker. 2-substance abuser or dependence. 3-history of other psychiatric illness. 4-history of other neurological illness.
patient's perception of complications in implantology.

Conditions: Dental Implant Failed; Dental Prosthesis Failure

Summary: to assess the influence that the complications of implant treatment have on the patient's perception and satisfaction on treatment.

the study is carried out in 5 dental centers with similar socio-professional characteristics. the perception of patients with complications in implantology will be evaluated using a questionnaire. all patients who present some type of complication in a dental treatment with implants will be included. patients will be included both if they are aware of the complication, that is, they come to the consultation for it, and patients who are diagnosed with a complication in a routine check-up. patients will be informed of the complication and before explaining the treatment possibilities, their inclusion in the study will be formalized by signing the informed consent document. subsequently, they must fill out a questionnaire consisting of 5 questions about their perception of the complication and its influence on their quality of life. the researcher will record the technical data of the implant treatment as well as the patient's responses in the data table. after collecting a sufficient number of data, around 400 patients, the collaborating researchers will send their corresponding data tables to the main researcher who will be in charge of the statistical analysis together with obtaining the results.

Eligibility criteria:
inclusion criteria: patients form 18 to 95 years old. patients with dental implants supporting one o more implant prosthesis. patients presenting one treatment complication affecting either dental implant or implant prothesis. exclusion criteria: patients who does not accept informed consent and do not want to fill the questionnaire. patients with cognitive impairment. patients under psychiatric treatment.

Keywords: complication implant dentistry
safety and tolerability of the d1 dopamine receptor antagonist ecopipam in patients with lesch-nyhan disease

Conditions: Lesch-Nyhan Disease

Summary: the purpose of this study is to determine the effects of ecopipam in patients with lesch-nyhan disease (lnd). ecopipam specifically blocks the actions of one chemical in the brain that helps nerves talk to one another; ecopipam does this by stopping the chemical (dopamine) from binding to one of its family of receptors (i.e, the d1 family). lnd is a very rare genetic disease. the sponsor is doing this study to find out what side effects ecopipam causes in lnd patients, and whether ecopipam may be able to relieve the self-injurious behaviors seen in these patients.


Eligibility criteria:
inclusion criteria * diagnosis of lesch-nyhan disease with moderate to severe self- injurious behavior and are routinely restrained * male - 6 years of age and above * body weight greater than or equal to 44 pounds exclusion criteria: * taking neuroleptic or dopamine depleting medications * currently treated with medications for depression or seizures * impaired renal function * medical conditions that may interfere with completing the study

Keywords: ecopipam lesch-nyhan disease safety self-injurious behavior
t and b cell response to avian flu vaccine

Conditions: Influenza

Summary: the purpose of this substudy study is to evaluate the types of cells involved in fighting infection to the a/h5n1 (avian flu virus) vaccine. a maximum of 30 healthy adults ages 18-64 years, enrolled at stanford university hospital and participating in another clinical trial (dmid protocol 04-062) will be enrolled into this substudy to collect additional samples of blood for testing before and approximately one week after each vaccination.

a human vaccination trial involving influenza a/h5n1 vaccine with different adjuvants is being conducted in a healthy adult population aged 18-64 years (dmid 04-062) to test the safety, reactogenicity, and immunogenicity of monovalent inactivated influenza a/h5n1 vaccine when given with either alone (no adjuvant), or given along with either alum or mf59. two doses of the vaccine/adjuvent will be administered day 0 and day 28. this study is linked to dmid protocol 04-062. this protocol is a substudy to collect additional blood samples to specifically evaluate the cell-mediated immune responses generated from the vaccine. primary goals of this study are 1) to establish reproducible, functional cell-mediate immune response assays to evaluate the magnitude and functional capacity of b cells, nk cells and t cells responding to monovalent subvirion h5 influenza vaccine 2) to evaluate the percent of subjects demonstrating b cell, nk cell, cd8+ and/or cd4+ response. the secondary goal of this study is to examine and compare the adjuvant effect of alum or mf59 compared to no adjuvant on cell mediated immune responses.

Eligibility criteria:
inclusion criteria: 1. all subjects who are eligible and enrolled in 04-062 and have agreed to the extra blood draws for this substudy will be considered for enrollment if they will be receiving 15 micorgrams of the h5n1 vaccine without an adjuvant or with 15 micrograms of the h5n1 vaccine with alum or mf59 adjuvant. subjects will not be recruited outside the main vaccine trial. 2. subjects who understand and sign the consent form for this study. 3. subjects who meet pre-screening qualifications will be eligible for the initial pre-vaccination blood draw. exclusion criteria: 1. all subjects who are ineligible for the main monovalent subvirion h5 vaccine trials will not be eligible for the cmi sub-study.

Keywords: vaccine, influenza, a/h5n1, cmi, sub-study
catheter over needle vs catheter through needle

Conditions: Nerve Block; Catheterization

Summary: to randomize 108 patients undergoing knee replacement surgery to catheter through needle or catheter over needle femoral nerve blocks, then monitor the catheters for leakage to see if there is a difference.

background: total knee replacement surgery is a commonly performed procedure that causes significant post-operative pain. continuous femoral nerve blocks are widely used for analgesia as part of a multimodal analgesic regimen for this surgery. they provide sustained analgesia which allows early physiotherapy for rehabilitation. currently the most common technique for inserting catheters for continuous femoral nerve blocks is to feed a catheter though a needle (ctn) which has been placed close by the nerve. there is a significant rate of leak and dislodgement of these catheters which can lead secondary failure where the catheter is no longer providing analgesia by blocking the nerve (primary failure occurs when the nerve block catheter fails to provide any analgesia from the start). the system to be investigated has a catheter over the needle (con) which is left in place after the needle is withdrawn. the proposed benefit of this is that there will be a reduction in leak rates and dislodgement. this is because using a con technique means that the biggest hole will be the diameter of the catheter, rather than ctn where the biggest hole will be the diameter of the needle therefore allowing leak around the outside of the catheter. objectives: to ascertain whether or not the catheter over needle technique is superior to catheter through needle technique in terms of a leak rate. trial plan: to recruit 108 patients who are having total knee replacement surgery into the study and randomise them into having either con or ctn continuous femoral nerve blocks.

Eligibility criteria:
inclusion criteria: * patients presenting to sir charles gairdner hospital for elective, unilateral, primary total knee replacement. * body mass index 18-40 kg/m2 * american society of anaesthetists (asa) grade i-iii exclusion criteria: * allergy to local anaesthetic * inability to cooperate * inability to read, speak and understand english * less than 18 years old

Keywords: nerve block catheter catheter over needle femoral nerve anaesthesia [e04.525.210.550] [e02.148]
intranasal dexmedetomidine for pain management during screening for retinopathy of prematurity

Conditions: Retinopathy of Prematurity; Dexmedetomidine

Summary: background: preterm infants undergo serial eye examinations during their hospital stay to monitor for the development of a specific disease termed "retinopathy of prematurity". while those examinations are known to cause significant pain and stress, the current standard of care (sucrose and local anesthesia) is not adequate in terms of alleviation of pain. purpose: the goal of this clinical trial is to test the effectiveness of dexmedetomidine for pain management in preterm infants undergoing routine eye examinations. the main questions it aims to answer are: * does dexmedetomidine reduce the pain scores of preterm infants during and shortly after eye assessments in comparison to placebo (saline 0.9%). * does dexmedetomidine cause more adverse effects than placebo. in this crossover study participants will receive either dexmedetomidine or saline 0.9% intranasally 30 minutes before the examination, on top of the current standard of care. the participants will be monitored closely for 5 hours to note differences in adverse effects. the researchers will use video monitoring to assess the pain scores using a standardized and validated scoring system.


Eligibility criteria:
inclusion criteria: * gestational age \< 31 weeks post-menstrual age, or birth weight \< 1500 grams * informed consent signed by one of the parents exclusion criteria: * invasive ventilation at the time of the eye assessment * multiple congenital anomalies * chromosomal / genetic anomalies * infant received a sedative drug in last 5 days * eye examination for reasons other than retinopathy of prematurity screening * attending physician deemed the patient not stable enough

Keywords: retinopathy of prematurity dexmedetomidine pain analgesia premature infant pain profile - revised
the diagnosis of oral allergy syndrome through the use of a structured questionnaire

Conditions: Food Allergy

Summary: oral allergy syndrome is a type of food allergy which mainly affects people with springtime hay fever. it is caused by a cross-reaction, between antibodies to pollens, usually birch tree pollen, and allergens in many different plant foods. it is characterised by symptoms of itching and/or swelling in the mouth and/or throat when eating certain fruits vegetables and nuts. many of the allergens causing oas are destroyed by heat, making allergy testing using traditional allergen extracts unreliable. prick testing or challenging with fresh foods is more reliable, but time consuming, inconvenient and largely unavailable. pilot study results suggest the characteristic symptoms and foods involved in oas allow accurate diagnosis using clinical history alone, which forms the basis for the hypothesis of this proposal that oas can be diagnosed accurately by use of a validated questionnaire alone. the diagnostic questionnaire (pfsdq), revised from the results of the pilot study, will be tested against two reference test methods, the gold standard of oral food challenge, and the 'platinum standard' of diagnosis made by a medical expert based on history, skin prick testing and oral food challenge. this is not an epidemiological study but with no published studies on oas in a uk population, this study will also provide some information on the prevalence of oas in those with springtime hayfever in the uk.


Eligibility criteria:
inclusion criteria: * symptoms of seasonal allergic rhino-conjunctivitis with/without seasonal asthma from march to may exclusion criteria: * below the age of 18 years, had poorly controlled concomitant asthma (forced expiratory volume in one second (fev1) \<70% predicted), any significant pre-existing medical condition, were pregnant or required β-blocking agents, h1-receptor antagonists or glucocorticosteroids on a continuous basis.

Keywords: oral allergy syndrome food pollen
evaluation of the goldstein sonobiopsy™ catheter for diagnosing endometrial pathology

Conditions: Menorrhagia; Endometrial Neoplasms; Polycystic Ovary Syndrome; Uterine Neoplasms

Summary: to assess the adequacy of an endometrial biopsy sample obtained using sonohysterography.


Eligibility criteria:
inclusion criteria: * patient with thickened endometrium * abnormal uterine bleeding exclusion criteria: * pregnant * active pelvic infection * pelvic inflammatory disease * blood clotting disorders * sexually transmitted disease * uterine perforation * recent cesarean section

Keywords: biopsy endometrial biopsy endometrial sampling sonohysterography